the clinical outcome camparison between covered …...the clinical outcome camparison between...
Post on 19-Jul-2020
1 Views
Preview:
TRANSCRIPT
The clinical outcome camparison between covered
stent(CV) and drug-eluting balloon(DEB) for SFA lesions:
a single center result
Li Ming MD
Associated Professor in Vascular Surgery
2nd Xiangya Hospital, CSU
Provincial Center of Major Vessel Disease in Hunan
Vascular Surgery Center of CSU
Disclosure
Speaker name:
..Li Ming...............................................................................
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
R I do not have any potential conflict of interest
Background
Background
Viabahn for femoropopliteal in-stent restenosis. Al Shammeri O, Bitar F, Ghitelman J,
Soukas PA. Ann Saudi Med. 2012 Nov-Dec;32(6):572-82.
Background
Method
From 2015.6 to 2017.6, 53 patients’ data were reviewed
CS group: 32 pts, DEB group: 21pts
Inclusion criteria:
Rutherford 2-5
DE novo or ISR
SFA occlusive lesions >10cm
Post-op management: Clopidogrel 75mg +Aspirin 100mg
Baseline Characteristics
Characteristics CS group (n=32) DEB group(n=21) P Value
Age 65.66±12.35 64.05±12.81 1.000
Male 28(87.5%) 18(85.7%) 0.8510
Smoker 25(78.1%) 16(76.2%) 0.8693
Hypertension 13(40.6%) 10(47.6%) 0.6153
Hyperlipidemia 18(56.2%) 11(52.3%) 0.7820
CHD 12(37.5%) 8(38.1%) 0.9651
Diabetes 10(31.3%) 7(33.3%) 0.8737
Clinical Data
Characteristics CS group (n=32) DEB group(n=21) P Value
Rutherford 2 6(18.8%) 7(33.3%) 0.2275
Rutherford 3 13(40.6%) 6(28.6%) 0.3708
Rutherford 4 7(21.9%) 4(19.0%) 0.8039
Rutherford 5 6(18.8%) 4(19.0%) 0.9784
ISR 12(37.6%) 8(38.0%) 0.9651
Length of treated vessel(mm,Average)
285.9 233.3 P<0.01
Diameter of treatedvessel(mm,Average)
5.13 5.24 0.4796
Peri-operative Complications
Complications CS group (n=32) DEB group(n=21) P Value
MI 1 1 0.7597
Stroke 0 0
Renal failure 2 1 0.8187
Infection 0 0
Distal embolism 0 1 0.2127
Hematoma 0 0
Pseudoaneurysm 0 0
Overall death 1 0 0.4134
Procedure related death
0 0
Results
Complications CS group (n=32) DEB group(n=21) P Value
Amputation 0 0
Overall death 2(6.3%) 1(4.8%) 0.8187
Operation related death
0 0
Primary Patency@1 year
16(50%) 13(61.9%) 0.4673
Secondary Patency@1 year
26(81.2%) 18(85.7%) 0.6720
Results(ISR subgroup)
Complications CS group (n=12) DEB group(n=8) P Value
Mean length(mm) 254.8 184.0 P<0.01
Mean Diameter(mm) 5.17 5.19 0.9252
Amputation 0 0
Overall death 0 0
Operation related death
0 0
Patency rate(@6 months)
83.3% 87.5% 1.0
Patency rate(@12 months)
58.3% 75% 0.4439
Discussion
Author Year 1 2 3 4
Lammer 2000 Radiology, 217:95-104 80 13.8 NR 79
Jahnke 2003 J Vasc Interv Radiol, 14:41-51 52 8.5 83 78 74 62
Bleyn 2004 Edizioni Minerva Medica, 14:87-91 67 14.3 100 82 73 68 54
Panetta 2005 Endovasc Today, August 41 30.4 90 86 77
Chopra 2006 AIM Symposium, November 13-16 70 20 71 93 87 72
Coats 2006 Endovasc Today, September 83 NR 47 89
Fischer 2006 J Endovasc Ther, 12:281-16 59 10.7 87 67 58 57 52
Zander 2006 SIR Meeting, April 3 31 16.6 NR 86 78 78 78
Saxon 2007 J Vasc Interv Radiol, 18:1341-1350 87 14.2 42 76 65 60 55
Alimi 2008 Eur J Vasc Endovasc Surg, 35:346-352 102 11.7 NR 74 71 71
Djelmami-Hani 2008 SCAI Meeting, March 29 - April 1 132 21 39 80
Saxon 2008 J Vasc Interv Radiol, 18:823-832 97 7 21 65
VIBRANT 2009 VIVA, September 19-22 72 19 60 53
Kougias 2009 Am J Surgery, 198:645-649 31 23 100 75
Farraj 2009 J Invasive Cardiol, 21:278-281 32 15.4 100 80
Rabellino 2009 Cath Cardiovasc Interv, 73:701-705 32 NR NR 82 75 75 75
McQuade 2010 J Vasc Surg;in press 50 25.6 NR 72 63 63 59
Average / Total 1103 16.2 62 78 72 67 59
NR = Not Reported
Reported patency rates of GORE VIABAHN® Endoprosthesis / GORE HEMOBAHN
Endoprosthesis (5-8mm) treating the SFA in Studies of at least 30 limbs (updated 20-Jul-10)
Primary Patency
(years / %)No. of
Limbs
%
Occlusions
Lesion
Length
(cm)Journal Publication / Presentation
Discussion
Study name DEB name/manufacturer
Mean lesion length(mm)
POBA DEB
Patency rate(12 months)
DEB POBALEVANT 2 Lutonix 63.2 62.7 65.2% 52.6%
IN. Pact SFA IN.PACT 89.4 88.1 82.2% 52.4%
BIOLUX PI Passeo-Lux 51.4 68.5 84% 47.1%
Acocath AcoTec 152 147 76.1% 33.7%
ILLUMENATE Pivotal Study
Stellarex 80 89 82.3% 70.9%
Discussion
Our 12 months patency rate of CS andDEB are 50% and 61.9% respectively, bothare lower than literature
Probably due to longer lesion length andhigh percentage of CTO lesion
Discussion
Complications CS group (n=32) DEB group(n=21) P Value
Stop medicationrate
3(9.4%) 6(28.6%) 0.1315
Modified patency rate
55.2% 76.7% 0.066
Discussion-ISR subgroup
Complications CS group (n=12) DEB group(n=8) P Value
Mean length(mm) 254.8 184.0 P<0.01
Mean Diameter(mm) 5.17 5.19 0.9252
Patency rate(@6 months)
83.3% 87.5% 1.0
Patency rate(@12 months)
58.3% 75% 0.4439
Discussion-ISR subgroup
The Treatment of Superficial Femoral Artery In-Stent Restenosis:
The Jury Is Still Out. Gray BH et al. JACC Cardiovasc Interv. (2016)
Discussion-ISR subgroup
Conclusion
Real world experience comparing CS and DEB
DEB showed advantage over covered stent in treating SFA long lesion
Covered stent still plays a role in PAD treatment, especially for ISR
More data and longer follow-up time is needed
Thank you for your attention!
谢谢!
The clinical outcome camparison between covered
stent(CV) and drug-eluting balloon(DEB) for SFA lesions:
a single center result
Li Ming MD
Associated Professor in Vascular Surgery
2nd Xiangya Hospital, CSU
Provincial Center of Major Vessel Disease in Hunan
Vascular Surgery Center of CSU
top related